RAC Certification Holders Needed

RAPS is seeking RAC credentialed volunteers to support the Standard Setting meeting for the RAC programs. This meeting is a key step in the exam development process and helps ensure that the exam remains fair, valid, reliable, and aligned with expectations for competent regulatory practice.

Volunteers will review exam items, conduct quality assurance checks, and collaborate with the exam vendor to help establish the minimum passing standard for the certification exam. The group will meet in person for two full days at the RAPS office in Rockville, Maryland.

Volunteer tasks may include:

• Reviewing exam items for clarity and relevance
• Evaluating the expected performance of a minimally qualified candidate
• Using rating methods to determine the passing standard
• Discussing item difficulty and expected competency levels
• Ensuring the exam accurately reflects the knowledge needed for safe and effective regulatory practice

Why volunteer for the RAC Standard Setting meeting?

• Make a meaningful contribution to the RAC certification program
• Strengthen the certification and support the regulatory profession
• Gain experience in the Standard Setting process and exam development
• Network with experienced regulatory affairs professionals
• Gain insight into the scope and expectations of regulatory practice
• Earn 12 RAC recertification credits
• Help shape the future of the profession

Requirements:

• Must be able to meet in person at the RAPS office (Rockville, MD) for 2 full consecutive days between 2-3 June 2026. Travel expenses will be reimbursed.

• Must be a current RAC certification holder.
• Must have a minimum of 3 years of regulatory experience related to drugs or medical devices
• Must hold a regulatory position or be a first-line supervisor in one of the following areas:
  • Regulatory affairs
  • Clinical research
  • Quality Assurance